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Comparison of Intramuscular vs Intravenous Sedation in Dental Treatment

Comparison of the Sedative Effects of Intramuscular vs Intravenous of Ketamine, Midazolam and Atropine Cocktail in 2-6-Year-Old Uncooperative Dental Patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180401039166N1
Enrollment
32
Registered
2025-01-31
Start date
2025-01-04
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intramuscular and intravenous sedation.

Interventions

Intervention 1: Intervention group: Intramuscular injection:Drugs used in the intramuscular group include the combination of 6 mg/kg of ketamine (500 mg/10 ml, EXIR, Iran), 0.05 mg/kg of midazolam (0.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Uncooperative 2–6-year-old children with definitely negative or negative Frankl scores, who were referred to the Pediatric Dentistry Fellowship Clinic at the Dental School of Shahid Beheshti University of Medical Sciences, Tehran, Iran, and required at least 2 similar dental treatment visits.The subjects were included if they were classified as ASA I, according to the American Society of Anesthesiology (ASA).

Exclusion criteria

Exclusion criteria: Children with nasal obstruction, respiratory infections, limitations in neck movement, macroglossia, tonsil hypertrophy, micrognathia, or limitations in mouth opening were excluded.

Design outcomes

Secondary

MeasureTime frame
Physiological parameters. Timepoint: T0: the beginning of work; T1: after anesthesia injection; T2: 15 minutes after starting work, T3: 30 minutes after starting work and T4: end of work. Method of measurement: Data table.

Primary

MeasureTime frame
The level of sedation and behavioral evaluation based on the Houpt criterion. Timepoint: T0: the beginning of work; T1: after anesthesia injection; T2: 15 minutes after starting work, T3: 30 minutes after starting work and T4: end of work. Method of measurement: Houpt Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeila Eftekhar

Shahid Beheshti University of Medical Sciences

leila.eftekhar.a@gmail.com+98 21 2217 5351

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026